05 Nov FDA lowers regulatory hurdle for digital mammography

DiagnosticImaging.com | November 4 – For the vast majority of medical imaging devices, passing FDA review is a snap: Show equivalence to a device already on the market, wait a few months, and release the announcement that your new product is ready for U.S. patients. But not for full field digital mammography systems.

Since the first FFDM – the GE Senographe 2000D – passed FDA muster nearly 11 years ago, every FFDM device has had to go through the premarket approval system, a lengthy and often torturous process akin almost to the drug approval process.

As each subsequent application went through the wringer, regardless that each device was based on the same underlying digital technology as the one before, hundreds of far more complex machines, some representing new generations of technology in CT, MR and ultrasound, skated through the 510(k) process. The irony has not been lost on the FDA, which four years ago announced its intent to downgrade FFDM systems to Class II.

In May 2006, the FDA publicly discussed plans to reclassify FFD mammography systems from Class III to Class II. Two years later the agency released for public comment a draft guidance describing the proposed reclassification. A public meeting followed in November 2009 during which the draft guidance was discussed. Yesterday, Nov.4, the FDA made the reclassification official.